Treat-to-Target thyroid-stimulating hormone receptor antibody (TRAb) in Graves’ Disease

Phase 4

• Conditions: Graves' disease; Metabolic and Endocrine - Thyroid disease

• Registration Number: ACTRN12615000362594
• Lead Sponsor: Royal Brisbane & Women's Hospital Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-21
• Study Completion: 2016-11-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

First presentation of Graves’ disease as defined as hyperthyroidism (free T4 and/or free T3 above the upper limit of normal with TSH suppressed below the lower limit of normal - <0.3mU/L) associated with elevated TSH-receptor antibody (TRAb) (>1.5 U/mL)

Exclusion Criteria

- Greater than three months since first diagnosis of Graves’ disease
- Age less than 18 years
- Current or planned pregnancy within the next three years
- Current breastfeeding
- Clinical or imaging suspicion of thyroid cancer
- TRAb negative status at time of diagnosis,
- Potential participant or treating physician desire primary treatment with surgery or radioiodine therapy
- Concomitant treatment with lithium, corticosteroids, amiodarone, Lugol’s iodine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse of hyperthyroidism (defined as TSH <0.3 mU/L on blood serum assay)[12 months after cessation of carbimazole treatment]

Secondary Outcome Measures

Name	Time	Method
Relapse of hyperthyroidism (defined as TSH <0.3 mU/L on blood serum assay)[24 months after cessation of carbimazole treatment];Cumulative exposure to carbimazole (calculated on prescribed daily dose)[Within treatment phase with carbimazole];Adverse effects of carbimazole therapy (including: rash, gastrointestinal intolerance, significant impairment of liver synthetic dysfunction; or agranulocytosis - neutrophil counts < 0.5x10exp9/L)<br>[Within treatment phase with carbimazole];Incidence of new onset Graves’ eye ophthalmopathy by blinded assessment, as defined by the NOSPECS criteria[24 months after cessation of carbimazole treatment];Quality of life (AQOL-6 and ThyPRO)[24 months after cessation of carbimazole treatment];Mortality[24 months after cessation of carbimazole treatment];Health care associated costs, with incremental cost-effectiveness ratio of treating-to-target over standard care from a health service perspective[24 months after cessation of carbimazole treatment]